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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR TIPRANAVIR


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505(b)(2) Clinical Trials for tipranavir

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT02244190 ↗ Bioequivalence of Two Different Oral Solutions Tipranavir Administered in Combination With Ritonavir to Healthy Volunteers Completed Boehringer Ingelheim Phase 1 2008-04-01 To establish the bioequivalence of the new tipranavir oral solution formulation with the current tipranavir oral solution formulation following single-dose administration. In each case, 500 mg tipranavir was coadministered with 200 mg ritonavir.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for tipranavir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00034866 ↗ Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals Completed Boehringer Ingelheim Phase 2 2002-04-01 The purpose of this research study is to determine which of three different dose combinations of tipranavir and ritonavir, when taken with a standard approved anti-HIV drug therapy, is most effective and safe. Tipranavir is an investigational protease inhibitor which has been demonstrated to have in vitro activity against HIV-1.
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed PENTA Foundation Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00054717 ↗ Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST) Completed Boehringer Ingelheim Phase 3 2003-01-01 Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.
NCT00056641 ↗ Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients Completed Boehringer Ingelheim Phase 2 2003-01-01 This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients. The primary objective is to determine the safety and pharmacokinetics of: TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).
NCT00062660 ↗ Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection Approved for marketing Boehringer Ingelheim 2003-05-01 To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved treatments for HIV infection, who are unable to participate in another tipranavir controlled clinical trial and have an urgent need for anti-HIV treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for tipranavir

Condition Name

Condition Name for tipranavir
Intervention Trials
HIV Infections 34
Healthy 26
Infection, Human Immunodeficiency Virus 2
Hepatic Insufficiency 2
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Condition MeSH

Condition MeSH for tipranavir
Intervention Trials
HIV Infections 37
Infections 6
Communicable Diseases 6
Infection 5
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Clinical Trial Locations for tipranavir

Trials by Country

Trials by Country for tipranavir
Location Trials
United States 274
Canada 34
Australia 15
Germany 13
Spain 12
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Trials by US State

Trials by US State for tipranavir
Location Trials
Texas 15
Florida 13
California 13
New York 12
North Carolina 12
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Clinical Trial Progress for tipranavir

Clinical Trial Phase

Clinical Trial Phase for tipranavir
Clinical Trial Phase Trials
Phase 4 5
Phase 3 8
Phase 2/Phase 3 2
[disabled in preview] 45
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Clinical Trial Status

Clinical Trial Status for tipranavir
Clinical Trial Phase Trials
Completed 54
Terminated 9
Approved for marketing 3
[disabled in preview] 2
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Clinical Trial Sponsors for tipranavir

Sponsor Name

Sponsor Name for tipranavir
Sponsor Trials
Boehringer Ingelheim 56
GlaxoSmithKline 3
Germans Trias i Pujol Hospital 2
[disabled in preview] 6
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Sponsor Type

Sponsor Type for tipranavir
Sponsor Trials
Industry 64
Other 18
NIH 5
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